The Siteman Cancer Center has placed the highest priority on ensuring the safety of patients participating in clinical trials. The SCC Data and Safety Monitoring Plan (NCI-approved in 2002) was developed to coordinate and provide oversight for data and safety monitoring for all cancer-related trials consistent with the National Institutes of Health Policy for Data and Safety Monitoring. Every clinical trial conducted at the Siteman Cancer Center must include a plan for data and safety monitoring. In addition, all institutional investigator-initiated clinical trials receive regular stringent quality assurance and safety monitoring. Oversight of data and safety monitoring is the responsibility of the Siteman Cancer Center Quality Assurance and Safety Monitoring Committee (QASMC). The QASMC independently reviews studies and has the power to close or suspend studies as warranted. Decisions, findings, and actions are communicated to the Protocol Review and Monitoring Committee (PRMC) (Section 9.2). The QASMC provides the following services for all institutional investigator-initiated clinical research studies: Independent oversight, performance and review of quality assurance audits Review and oversight of reportable adverse event (RAE) reporting Review and oversight of interim safety and monitoring reports